Registered with FDA
Nouvatec LLC
Walnut Springs, TX, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Nouvatec LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Lister | Nouvag AG | 2025 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | Nouvag AG | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Nouvatec LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Nouvag AG (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 3 Nov 2004 | K042434 | MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 | Nouvag AG | DZI Powered Bone Drill |
| 1 Oct 2003 | K022505 | CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068, | Nouvag AG | EGS Dental Contra- and Right-Angle Attachment Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Nouvatec, LLCFDA reg. 3012607373 | Walnut Spgs, TX, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052407). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.